VAPR 225305Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705009299), received between Sep 25, 2019 and Nov 9, 2020 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K082643); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 9, 2020Excessive Heating; Excessive Heating

  IT WAS REPORTED THAT THIS WAS AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) PERFORMED ON (B)(6) 2020. WHEN THE SURGEON USED THE ELECTRODE FOR A RELATIVELY LONG TIME DURING THE PROCEDURE, CONTACT FAILURE OCCURRED. THE SURGEON WAS NOT MUCH CONCERNED ABOUT THE TEMPERATURE OF REFLUX FLUID. IT WAS POSTOPERATIVELY FOUND THAT THE PATIENT HAD SUFFERED FROM MILD BURN AROUND THE LESION AREA. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. WE WENT ATTENTION TO THE SALES REP TO COMPLY WITH THE PRESCRIBED REPORTING DATE. NOTE: THIS (B)(4) ARE SEPARATE CASES WITH THE SIMILAR NATURE OF THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 10813980 ↗
• InjuryNov 9, 2020Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT THIS WAS AN ARCR (ARTHROSCOPIC ROTATOR CUFF REPAIR) PERFORMED ON (B)(6) 2020. WHEN THE SURGEON USED THE ELECTRODE FOR A RELATIVELY LONG TIME DURING THE PROCEDURE, CONTACT FAILURE OCCURRED. THE SURGEON WAS NOT MUCH CONCERNED ABOUT THE TEMPERATURE OF REFLUX FLUID. IT WAS POSTOPERATIVELY FOUND THAT THE PATIENT HAD SUFFERED FROM MILD BURN AROUND THE LESION AREA. THE DEVICE WAS BRAND NEW AND THE FIRST USE WHEN THE ISSUE OCCURRED. WE WENT ATTENTION TO THE SALES REP TO COMPLY WITH THE PRESCRIBED REPORTING DATE. NOTE: THIS (B)(4) ARE SEPARATE CASES WITH THE SIMILAR NATURE OF THE EVENT.

  Patient problems: Burn(s)

  MAUDE report 10813927 ↗
• MalfunctionFeb 11, 2020Blocked Connection; Blocked Connection

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING A KNEE ARTHROSCOPY THE VAPR 3.5MM HOOK 90 DEG FAILED. A SECOND HANDPIECE WAS USED TO COMPLETE THE PROCEDURE. 5 MINUTES DELAY REPORTED. NO PATIENT CONSEQUENCES. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE DEVICE WAS NOT RECOGNIZED BY THE VAPR MACHINE WHEN THE ELECTRODE WAS CONNECTED TO THE HANDPIECE. THEY TRIED A 2ND HANDPIECE. SAME RESULT. THEY OPENED A NEW VAPR HOOK ELECTRODE AND IT WAS RECOGNIZED BY THE MACHINE WHEN IT WAS CONNECTED TO THE HANDPIECE.

  Patient problems: Not Applicable

  MAUDE report 9696179 ↗
• MalfunctionSep 25, 2019Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AN ELECTRICAL FAILURE WAS SUSPECTED WITH THE REPORTED ELECTRODES: VAPR 3.5MM SIDE STR -EA AND VAPR 3.5MM HOOK 90 DEG -EA. DEVICES. THEREFORE, TRANSPIRATION COULD NOT BE PERFORMED DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGERY. IT WAS REPORTED THAT THE DEVICES WERE BRAND NEW AND ON THEIR FIRST USE WHEN THE ISSUE OCCURRED. THERE WAS A FIVE MINUTE DELAY IN SURGERY AND NO HARM TO THE PATIENT. IT WAS NOT REPORTED IF SPARE DEVICES WERE USED TO COMPLETE THE SURGERY OR IF THE SURGERY WAS COMPLETED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Not Applicable

  MAUDE report 9116220 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082643. One submission often covers many models, so check the product and lot details in each record.

• Z-0133-2013 · Mar 12, 2012 · Terminated
  DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency Syste
• Z-2301-2010 · Jun 7, 2010 · Terminated
  Mitek VAPR Side Effect Electrode (integrated) Product Code: 227301 The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and V